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Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

Primary Purpose

Coronary Disease, Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Health coaching
Usual care
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Disease focused on measuring Secondary Prevention, Health Promotion, Behavioral Medicine, Exercise Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).

Exclusion Criteria:

  • Bundle branch block or pacemaker rhythm
  • Limitation or contraindication to moderate physical activity (fast walking)
  • Unstable clinical situation
  • Communication difficulties due to language or sensorial deficiencies.
  • Lack of informed consent

Sites / Locations

  • Hospital de SabadellRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health coaching

Control

Arm Description

Outcomes

Primary Outcome Measures

Patients achieving recommended physical activity (>600 MET-minute/week)
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)

Secondary Outcome Measures

Cost-efficacy of coaching
Cost-efficacy will be measured using SF-12v2 quality of life questionnaire
Improvement on functional capacity
Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention

Full Information

First Posted
March 18, 2010
Last Updated
March 18, 2010
Sponsor
Corporacion Parc Tauli
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT01089842
Brief Title
Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention
Official Title
Randomized Clinical Trial to Assess the Efficacy and Cost-efficacy of Health Coaching to Promote Physical Activity in Secondary Prevention of Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Corporacion Parc Tauli
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of motivational interviewing-based coaching to increase physical activity to achieve guidelines recommendations for cardiovascular disease prevention.
Detailed Description
Cardiovascular diseases are the main cause of death in developed countries. Epidemiological studies have shown that a sedentary lifestyle is associated with an increased risk of cardiovascular diseases, mainly related to classical risk factors (obesity, diabetes, hypertension). International guidelines recommend, because of that, a minimum of 30 minutes per day at least 5 days per week of moderate physical activity for primary and secondary cardiovascular disease prevention. Physical inactivity is an increasing public health problem in developed countries. It is known that clinical advice has a poor efficacy to increase levels of physical activity on individuals and new strategies need to be developed. Coaching is a strategy of personal help that is being widely and successfully used in business world. It consists of an structured and individualized process of assistance to people to promote cognitive changes needed to achieve behavioural changes. It can be a complementary method to information and sanitary education emphasizing on consciousness and responsibility of the patient and is now starting to be used in medical practice. The purpose of the study is to define usefulness of an strategy based on coaching techniques to promote physical activity practice and healthy lifestyle on individuals with known coronary heart disease or cardiovascular risk factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Atherosclerosis
Keywords
Secondary Prevention, Health Promotion, Behavioral Medicine, Exercise Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health coaching
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.
Primary Outcome Measure Information:
Title
Patients achieving recommended physical activity (>600 MET-minute/week)
Description
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost-efficacy of coaching
Description
Cost-efficacy will be measured using SF-12v2 quality of life questionnaire
Time Frame
6 months
Title
Improvement on functional capacity
Description
Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week). Exclusion Criteria: Bundle branch block or pacemaker rhythm Limitation or contraindication to moderate physical activity (fast walking) Unstable clinical situation Communication difficulties due to language or sensorial deficiencies. Lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan R Guma
Phone
0034937231010
Email
jgumag@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan R Guma
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

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